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Recall Observatory FDA recall evidence

Device product

GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2195-2015

July 01, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 71699
Status
Terminated
Classification
Class II
Quantity
13 Units
Official record key
device-enforcement:Z-2195-2015

Official wording

Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information: Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570.

Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defects in the Tumor LOC software application that may potentially result in